Folks, maybe you have been tossing around the idea of attending this year’s World Stem Cell Summit, but you can’t quite make up your mind?

Let me help simplify the situation.

Do it.

There is a very special reason why you should.

Normally, I would recommend attending because it is the most invigorating three days any supporter of regenerative medicine could hope for.

You will spend time with 150 of the movers and shakers of the emerging field, make tons of important contacts, learn more new stuff than would seem possible—and it will be fun. This is the only meeting of its type in the world, and I never miss it. For all who work to make the dreams of cure a reality, it is “the Conference of Hope”.

But that is not the reason to attend.

Not this year.

You know me; for the past sixteen years I have worked to find a cure for spinal cord injury, so my paralyzed son Roman Reed might have a chance to walk again. I helped develop and pass a law to fund scientific research, the Roman Reed Spinal Cord Injury Research Act, which provided the first state-funded embryonic stem cell research in the world, research now approaching human trial through Geron.

For cure to happen, the entire field of regenerative medicine must move forward. I served on the board of directors for Proposition 71, the campaign to pass a $3 billion initiative, the California Stem Cells for Research and Cures Act, which passed.

And I held my breath in the audience, as President Obama signed a decree overturning the Bush administration’s restrictions…

Never have I felt so heartened, so full of hope.

And yet, we may lose it all, if the anti-science forces have their way.

If we do not unify in the next few weeks, we risk losing cure research for a generation.

And one political party has pledged to ban it altogether, public and private.

We must come together now: to plan, to strategize, to get ready for the greatest battle of our lives.

Please do not say, “I don’t have the time.” This is an emergency, and normal constraints do not apply.

Can’t afford it? Call the conference organizers and ask about reduced rate possibilities. I know Bernie Siegel, founder and co-chair of the World Stem Cell Summit, and he is dedicated to the pro-cures cause. He has always placed patients and their families first.

If I were a gambler, I would bet the house that Judge Royce C. Lamberth is going to declare federal funding of embryonic stem cell research to be against the law.

Far from being an objective and disinterested bastion of balance, I think the man has already made up his mind on the case: Sherley v. Sebelius.

There are several reasons for my opinion.

First, an organization called the Coalition for the Advancement of Medical Research (CAMR) applied to be part of the case. (Important: neither CAMR nor its attorneys has any connection to my opinions.)

CAMR is a group of nearly 100 organizations, large and small, made up of patients, advocates, scientists, doctors and educators. CAMR supports federal funding of embryonic stem cell research, and has unparalleled expertise in this area. For more than a decade, they have led efforts to defend scientific freedom and this research.

CAMR asked to be part of the case under the legal term amicus curiae (friend of the court), basically to be an expert witness.

Judge Lamberth refused. His reason for denying CAMR the right to participate?

“…plaintiffs did not have time to file a response to CAMR’s submitted brief.”

What?

The plaintiffs, the people trying to shut down embryonic stem cell research funding, did not have time to respond? That is the reason Judge Lamberth denied CAMR participation, blocking out the views of such groups as the Christopher and Dana Reeve Foundation?

If the plaintiffs needed more time to read a document, give it to them. CAMR’s brief is 11 pages, how long do they need? One day, two?

Or was that just an excuse to deny our strongest ally?

For whatever reason, that decision blocked out the representatives of 100 million incurable ill Americans and their families—we who might benefit from cure research.

Feels like stacking the deck to me.

There are further indications the judge appears to have sided with those who want to shut down embryonic stem cell research.

For example, note his comments:

“The injunction (to shut down the research while the trial drags on-DR)…would not seriously harm ESC researchers (emphasis added) because the injunction would simply preserve the status quo….”

Shutting off someone’s paycheck is not serious harm?

“The status quo” (the situation which exists right now) allows federal funding; the Judge’s injunction would stop the money. Cutting off a research grant stops the research—does that not alter the status quo?

But no, the judge says, the researchers could still get money somewhere else because the injunction “….would not interfere with their ability to obtain private funding for their research…”

This does not make sense.

If a robber empties my wallet, it seems to me I have been harmed, and my status quo has been altered, even if I am free to go and earn more money.

Researchers are no different. If their funding is cut off, they are out of a job. Saying they can go apply for funding somewhere else does not alter the fact they have suffered “serious harm” and their status quo has very definitely not been “preserved”.

What would CAMR have said, if allowed to participate? We cannot know, of course, since their inclusion was denied. But here is one paragraph, taken from their formal request for inclusion, a public document.

“”Far from preserving the status quo, the preliminary injunction will, if not stayed, radically disrupt, and perhaps permanently cripple, ongoing and planned hESC research that has been funded through successive administrations of both political parties, with the acquiescence and endorsement of Congresses controlled by both political parties, in conformity with Guidelines designed to assure that the research is conducted ethically, in accordance with the highest standards of medical science.”

Unfortunately, CAMR was not welcomed in Judge Lamberth’s court.

But wait, there’s more. Listen to the judge expressing his (non-expert) opinion on the embryonic stem cell research itself.

“…(curing) diseases that one day may be treatable as a result of ESC research is speculative. It is not certain whether ESC research will result in new and successful treatments for diseases such as Alzheimer’s and Parkinson’s disease.”

By this logic we should cease to fund the research, because it is “speculative”?

Is there any research which is not speculative?

Nothing in science—or in life– is certain. Cure is not guaranteed by anyone except charlatans and frauds. The hope of cure is all we ever have, even with the most established traditional procedures. One of my relatives went into the hospital for a knee operation; a blood clot blocked an artery, shut off blood flow to the brain, and she died.

Any operation has risk, which is why you sign those forms beforehand, in case you die.

But what if the judge is wrong? If he shuts off funding for research which (years later) turns out to be valuable, he would be responsible for having perpetuated the suffering and premature loss of life of uncountable people, ruining their families’ happiness: and wreaking havoc with our economy, increasingly unable to deal with a growing mountain of medical debt. Do you know that last year America spent $1.65 trillion on incurable disease (exactly the kind of illness hESC research targets)—more than all federal income taxes ($1.2 trillion) combined?

What might CAMR have said, if allowed to testify? We cannot know, of course, because of Judge Lamberth’s decision.

However, again from their request, that 11 page document which took me half an hour to read but which according to the judge was too time-consuming for the plaintiffs:

“Research already has begun to demonstrate the types of treatments that could result from further hESC research. For example, researchers have been able to direct hESC differentiation to produce specific types of cells that could be used in the treatment of Parkinson’s disease and Type 1 diabetes. The first clinical trials using hESCs for spinal cord injuries and for blindness have been approved by the Food and Drug Administration and are set to begin soon. Other major, potentially groundbreaking and life-saving research is ongoing, as demonstrated by the many peer-reviewed articles that address hESC research published since 2002. The preliminary injunction, which will severely disrupt and, in the case of some ongoing experiments, destroy hESC research will have very real, large, and immediate consequences for both researchers and the millions of patients in urgent need of scientific advances in their medical treatment.”

–both this and the preceding CAMR quote are taken from the “Brief Amicus Curiae of Coalition for the Advancement of Medical Research in Support of Defendants Emergency Motion to Stay Preliminary Injunction Pending Appeal”, submitted by:

Remember those two adult stem cell researchers who worried that allowing embryonic stem cell research funding might mean less money for them? (That is their sole standing in the case.) The Judge says James L. Sherley and Theresa Deisher would suffer “immediate and irreparable” damage, if they had to compete for limited funding.

Their plight appears to have touched the judge’s heart—even though one of them already has two grants from the government, (Sherley) and the other (Deisher) has never applied for one. Listen to the judge’s words:

“Plaintiffs’ injury of increased competition… is actual and imminent. Indeed the Guidelines threaten the very livelihood of plaintiffs Sherley and Deisher…the irreparable harm that plaintiffs would suffer…. outweighs the harm to interested parties.”

See what is happening here?

By focusing on these two allegedly suffering scientists, the judge has narrowed the case– and the people most affected by it are left out.

My son Roman, paralyzed sixteen years? If CAMR was allowed in the case, he would be represented. My small group, Californians for Cures, is among the members of CAMR. Denying CAMR denies us. According to the judge’s opinion, we are apparently not “interested parties”— though hESC research may be our best hope for Roman’s cure.

This case is not a minor dispute between a governmental agency and two scientists; it is perhaps the most important decision in the history of American medicine:

Should science and government determine medical research policy, so that every American family can have access to the best medicine science can provide—or will that research be chilled, controlled, and limited by the religious right and its political allies?

Judge Lamberth appears to have taken a side. He seems to me to be what conservatives call an “activist judge”: someone who uses the law to advance a political cause. I have heard anecdotally that he personally opposes the research. By his actions, this would appear to be accurate.

Maybe I am wrong. Maybe this Texas Republican will judge the case on its merits and leave his party politics outside the door.

But if this were a card game, I would say we need a fresh deck– and a new dealer.

Below is an unofficial copy of the document rejecting CAMR’s involvement, followed by a listing of groups represented by that organization.

SHERLEY et al v. SEBELIUS et al doc 54

Case 1:09-cv-01575-RCL Document 54 filed 09/07/10 page 1 of 1

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

JAMES L. SHERLEY, et al, Plaintiffs. V. KATHLEEN SEBELIUS, in her official capacity as Secretary of the Department of Health and Human Services, et al., Defendants

Civil Action No. 09-1575 (RCL) ORDER

Upon consideration of the Coalition for the Advancement of Medical Research’s (CAMR) Motion for Leave to File Brief Amicus Curiae (ECF No. 52) and the record herein, it is hereby ORDERED that the motion for leave to file is DENIED.

Defendants requested expedited consideration of their motion to stay, asking the Court to rule by today. Because the Court accommodated defendants request, plaintiffs did not have time to file a response to CAMR’s submitted brief. (emphasis added) Accordingly, although the Court typically welcomes amicus briefs, the Court did not have the opportunity for full briefing on the issues raised by CAMR. The Court thus reluctantly denies CAMR’s motion.

SO ORDERED.

Signed by Royce C. Lamberth, Chief Judge, on September 7, 2010

Finally, here is the group membership of the Coalition for the Advancement of Medical Research, which participation Judge Lamberth denied.

In a perfect world, he would be guaranteed research funding for the rest of his life.

But this is not a perfect world.

Hans Keirstead’s research depends on a constant search for funding.

Attempting to cure paralysis, California’s Roman Reed Spinal Cord Injury Research Act (named after my paralyzed son Roman) provided the initial funding which led to Keirstead’s groundbreaking success with spinal cord injury—the world’s first clinical trials with embryonic stem cells are now going forward with Geron.

That same research also offers hope to sufferers of Spinal Muscle Atrophy (SMA) a hideous disease that kills children, typically before the age of two.

Geron is also intending to take the same purified stem cell lines Keirstead developed into the battle against Alzheimer’s, the terrifying condition which robs sufferers of their memories—forgetting family, and the simplest mechanical procedures like how to turn out a light—and finally, how to breathe.

And blindness: to attack the fear of living in the eternal night of the unsighted, researchers led by Keirstead at UC Irvine have succeeded in getting stem cells to differentiate into a retina.
Help us help Keirstead, so he can advance the field of regenerative medicine.

Can you come? October 8, in an intimate surrounding, the Oakley Sunglass Stadium, Foothill Ranch, California.

If you can come, please do. Inconvenience yourself. Roman and I will be driving down from Northern California, and we both have major appointments the following day, so it will be about 16 hours in the car. But this is important. Come if you can—and share this announcement with friends.

P.S. If you follow the research, you know there is still another ideological attempt going on to block all federal funding of embryonic stem cell research. Hans Keirstead is one of the world’s leaders in this field. He won’t give up, but he needs funding to go on. Help if you can, but pass this message on, no matter what.

I contacted the committee, asking to submit written testimony, which follows below.

Most importantly– here is how you can speak to the power people who need to hear from you in Congress. Cut and paste it into your search bar: I guarantee you will be glad you did—then share it with your list of advocate friends—it is excellent, easy, and effective.

It is a wonderful (and simple!!!) way to reach all your Senators and Representatives in a one-click way. It has a message ready to go, but you can edit it in any way you like.

The widget is from Parkinson’s Action Network (PAN) and Amy Comstock-Rick, immediate past-President of the Coalition for the Advancement of Medical Research.

I hasten to add that neither Ms. Rick nor PAN have any connection to my opinions; I simply respect their work and am passing it along for your consideration.

Below is the testimony I submitted to the committee hearing. My title is given for purposes of identification only, and may or may not express the views of Americans for Cures Foundation.

Don C. Reed
Vice President, Americans for Cures Foundation
Testimony for the Record to
United States Senate Committee on Appropriations
Subcommittee on Labor, Health and Human Services, and Education, and Related Agencies
Hearing entitled: “The Promise of Human Embryonic Stem Cell Research”
September 16, 2010

Honorable Senators Tom Harkin and Thad Cochran, Members:

Thank you for this opportunity to provide testimony on a subject which affects one hundred million Americans with a chronic (incurable) disease or disability—and everybody who pays the medical bills.

The costs are staggering: last year, chronic illness cost America $1.65 trillion, more than all federal income taxes ($1.2 trillion) combined. The suffering is incalculable.

These are not empty statistics, but members of your family and mine: people like my son.

On September 10th, 1994, Roman Reed was playing college football. At middle linebacker he was having a great game: 11 solo tackles, a diving one-hand interception, a forced and recovered fumble.

And then—the accident. There was a hideous sound, like an axe handle breaking on a rock. In an instant our son was paralyzed from the shoulders down. He was nineteen.

The doctors gave us no hope.

“He will never walk again, nor close his fingers; almost certainly no children,” they said.

We would not accept that diagnosis then, and we do not accept it now. We worked to find a cure.
With the leadership of Fremont Assemblyman John Dutra, we passed a California law, Assembly Bill 750, the Roman Reed Spinal Cord Injury Research Act of 1999.

On March 1, 2002, I held in my hands a rat which had been paralyzed, but which walked again, thanks to embryonic stem cells—as my son watched from his wheelchair.
This was the famous experiment to re-insulate damaged nerves in the spine. Geron is taking it to the world’s first human trials of embryonic stem cells, recently approved by the FDA. Ten newly-paralyzed young men or women will be offered a chance my son did not: to maybe get better, through embryonic stem cell research.

“Roman’s law” funded the first use of the Presidentially-approved embryonic stem cell lines. And, importantly, the Federal government backed us up. For our total expenditure of $14 million over nine years, we brought in an additional $60 million in follow-up grants and matching funds from the NIH, new jobs and revenue. But it was not enough.

For cure to come, not only for paralysis, but also the dozens of incurable diseases afflicting so many, the entire field of regenerative medicine had to advance.

In 1942, research connected with the medical aspects of radiation sickness from the atomic bomb revealed that bone marrow transplants had healing properties. That was the beginning of adult stem cell research, which has proved extremely useful in the treatment of forms of cancer and blood disease.

But it is not the exclusive answer to all chronic illness and injury.

Embryonic stem cells which build every portion of the body are also important.

The difference between adult and embryonic stem cells is like the difference between gift certificates and cash money—one can only be spent in certain places, the other is acceptable everywhere.

For the field of regenerative medicine to advance, both types of cells are needed: each is different, and has different powers and purposes.

But there are subtle dangers to be aware of with adult stem cells. They cannot always do what embryonic stem cells can. Sometimes adult cells which have been experimentally turned into useful cells revert to their original adult stem cell state. One attempt to turn adult stem cells into nerve cells did not last, and after a few days, the rats which had the cells implanted developed excruciating pain, so they gnawed off their paws.

An approach I regard as a failure is the attempt to use Olfactory Epithelial Glia (OEGs) to restore spinal cord function, basically reaching a scalpel up into the nose and scraping off part of the brain, which is then spread like jelly on the injured spine. I have spoken with a recipient of that treatment who described (after an expenditure of approximately $40,000) the essential failure of it: the paralyzed person regained a patch of skin sensation on his elbow, so that he could feel his sleeve go on, when they dressed him in the morning.

Much has been said about “adult stem cell treatments for 70 diseases”, but this is misleading at best. Prescribing aspirin for cancer may be a treatment, but it is not a cure.

The ancient scientist Galen spread pigeon dung on the spines of paralyzed gladiators. It was a treatment, but hardly a successful one.

The idea of adult stem cells being ready to be the sole standard of treatment is not only unwise but cruel, imposing something unreliable in place of the possibility of actual cure.

California’s Bob Klein began an initiative, Proposition 71, the Stem Cells for Research and Cures Act. I was proud to serve on the Board of directors of that successful effort.

But even when 7 million voters approved the $3 billion stem cell program, lawsuits were hurled against us: frivolous in their grounds, but devastating in their consequences.

For almost two years the full program was held up. Research delayed is research denied. Who knows what might have been discovered during that time, if we had our program fully operational?

But we prevailed, and today the California Institute for Regenerative Medicine (CIRM) is the pride of our state and a friend to all the world.

Recently, four major grants, $20 million each, were awarded by the CIRM for embryonic stem cell research: Lou Gehrig’s disease, stroke, juvenile diabetes, and age-related blindness were chosen. Each is an attempt to do the impossible with the invisible: to try and heal a malady incurable since the dawn of time.

Cures the CIRM develops will benefit everyone; not only the individual families whose suffering will end, but also the economies of every nation, struggling to pay mountains of medical debt. All will benefit.

But we need the Federal government to help with the enormous costs which wait beyond initial research: the “valley of death” which faces all new medical discoveries: the costs of turning theory into therapy, all the way from bench to bedside, may approach a billion dollars. California’s program has a budge of approximately $300 million a year: we can’t do it alone.

March 9th, 2009, a day of joy. Roman, Gloria and I were in the room when President Barrack Obama reversed the Bush restrictions. Now, at last, the Federal government would take its rightful place, leading in the quest for cure.

But another obstacle arose. The case of Sherley v. Sebelius may shut down federal funding of the research so many patients and families have worked to advance.

The argument is often made by ideological opponents that embryonic stem cell research is a form of abortion.

This is false. How can there be an abortion, when there is no baby

There is no pregnancy in embryonic stem cell research. Nothing is placed in the womb. It is biologically impossible for an unemplanted blastocyst to become a child. It is living tissue, like a wiggling sperm, but not a life. It cannot possibly become a child without the nurturing protection of a mother’s womb. No mother, no baby: this is unarguable fact.

Congress had a full and vigorous debate on federal funding for the research: and approved it twice. The Stem Cell Research Enhancement Acts of 2005 and 2007 passed both houses with strong majorities. President Bush exercised his prerogative and vetoed both bills, but the will of Congress was crystal clear.

The Senate, the House of Representatives, and the President of the United States support federal funding of embryonic stem cell research.

If research funding is blocked for ideological reasons, we abandon a principle: that every American family deserves the best medical treatment science can provide.

Denying cure condemns two million paralyzed Americans like my paralyzed friend Karen Miner to a life sentenced incarcerated in a chair; it diminishes hope for those who suffer cancer and leukemia, which killed my mother and my sister Patty; and it slows the growth of jobs in America’s shining new industry: biomedicine.

Nine years ago, September 5, 2001, I provided testimony for Senator Edward Kennedy’s similar hearings on scientific freedom for stem cell research. I conveyed my son Roman Reed’s request, asking that the Senate:

“Take a stand: take a stand in favor of medical research; take a stand—so one day everybody can.”

Roman—and his wife Terri, and their three children, Roman Jr., Jason, and Katie—send that message again.

Finally, I would be remiss if I did not cite one of America’s greatest advocates.

The late Christopher Reeve sent a dictated letter to our family. It said: “One day, Roman and I will stand up from our wheelchairs, and walk away from them forever.”

Cure did not come in time for the paralyzed Superman, but we still believe in his great dream. Our champion has fallen, but the flame of his faith still lights our way. He always said, we must “go forward”. And we will go forward: because America has picked up the torch. Thank you.

Governor Schwarzenegger previously signed a renewal of that bill in 2005. It is due for renewal again. AB 1931, the renewal of “Roman’s Law”, has been approved by both houses with unanimous support: 32-0 in the Senate: 76-0 in the Assembly.

The renewal bill contains no request for general funds. (Funds will be sought from foundations, the federal government, and other sources.)

This law paid for the first state-funded embryonic stem cell research in America, re-insulating damaged spinal nerves. Laboratory rats so badly paralyzed they could only drag themselves are scampering now; that study goes to human trials with Geron. The same research may help cure Spinal Muscular Atrophy, (SMA, a vicious condition which kills children, often before the age of two), Multiple Sclerosis (MS), and other disorders.

“Roman’s Law” has helped train new scientists with fellowship grants, and assisted veterans to develop new approaches, from a variation of the Petri dish to pioneering new methods of rehabilitation and repair. In addition to 175 published scientific papers, two patents pending which may advance the biomedical industry, and several major scientific breakthroughs, our researchbrought new money to California.

Although we ask no state funding this year, our previous expenditures have been extraordinarily effective: attracting additional matching grants from the National Institutes of Health and other sources. Our total funding of $14 million was more than matched by $60 million from out of state—new jobs and revenue for California.